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FDA Approval

Ketorolac Tromethamine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 23, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ketorolac(30 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ketorolac Tromethamine

Product Details

NDC Product Code
50090-4635
Application Number
ANDA204216
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
June 20, 2019
alcoholInactive
Code: 3K9958V90MClass: IACT
KetorolacActive
Code: 4EVE5946BQClass: ACTIBQuantity: 30 mg in 1 mL
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
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